Outcomes of COVID-19 in patients with relapsing multiple sclerosis receiving ofatumumab: Data from the ALITHIOS study and post marketing surveillance

ABSTRACT

Introduction: Per WHO, >190 million people worldwide have been affected by COVID-19 as of 20-Jul-2021. Although people with MS are not at a higher risk of SARS-CoV-2 infection, factors such as age, comorbidity, MS severity and treatment with DMTs may affect COVID-19 severity and outcomes. Understanding the risks, severity and outcomes of COVID-19 in people with MS receiving DMTs, including anti-CD20 DMTs, is important to healthcare practitioners (HCPs) managing MS. Objectives: To report the characteristics and outcomes of COVID- 19 adverse events (AEs) in relapsing MS (RMS) patients taking ofatumumab enrolled in the ongoing, open-label, long-term extension Phase 3b ALITHIOS study and from post-marketing surveillance of people receiving ofatumumab 20 mg subcutaneously. Methods: Patient demographics, baseline characteristics, incidence of COVID-19 AEs, seriousness category (including hospitalization), severity, outcomes, ofatumumab exposure before the start of infection, and action taken with ofatumumab were assessed. Results: As of 29-Jan-2021, 139/1703 (8.2%) patients enrolled in ALITHIOS (mean±SD age at baseline 37.7±8.7 years;female, 64%) treated with ofatumumab reported COVID-19 AEs (confirmed 115 [82.7%];suspected 24 [17.3%]). Of these, 10 (7.2%) experienced COVID-19 serious AEs and all 10 (7.2%) were hospitalized. Most AEs reported were mild (Grade [G] 1;69 [49.6%]) or moderate (G2;62 [44.6%]) in severity. Severe (G3) and life threatening (G4) AEs were reported in 6 (4.3%) and 2 (1.4%) patients, respectively. One (0.7%) patient (48-year-old at COVID- 19 onset;BMI 28.3 kg/m2;recent MS relapse) with confirmed COVID-19 and pneumonia had a fatal outcome. At data cut-off, most patients (128 [92.1%]) had recovered from COVID-19 AEs;2 (1.4%) were recovering, 4 (2.9%) had recovered with sequelae and 4 (2.9%) had not recovered. COVID-19 AEs led to temporary interruption of ofatumumab in 22 (15.8%) patients. As of 31-Jan- 2021, an additional 28 RMS patients with COVID-19 AEs were identified in the Novartis safety database. Further details to be presented. Conclusions: In ALITHIOS, 139 RMS patients on ofatumumab reported COVID-19 AEs (as of 31-Jan-2021). Most (94%) COVID-19 cases were mild or moderate in severity. There were few hospitalizations but one fatal outcome. At data cut-off, most (92%) patients had recovered/resolved from COVID-19. ALITHIOS data extends the understanding of the long-term safety profile of ofatumumab in people living with MS.